Osteoarthritis of the KneePhase 2NCT01366014
A Study of ARRY-371797 in Patients With Osteoarthritis of the Knee
A Phase 2 study testing ARRY-371797, p38 inhibitor; oral and Oxycodone hydrochloride (HCl) extended release (ER), opioid agonist; oral in people with Osteoarthritis of the Knee, run by Pfizer at 13 sites in United States.
Trial summary
This is a Phase 2 study, involving a 4-week treatment period, designed to test the ability of investigational study drug ARRY-371797 to reduce pain in patients with moderate to severe pain due to osteoarthritis (OA) of the knee, and to further evaluate the drug's safety. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- ARRY-371797, p38 inhibitor; oral and Oxycodone hydrochloride (HCl) extended release (ER), opioid agonist; oral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 157 participants
- Where
- 13 sitesUnited States
- Study dates
- Jun 2011to Jun 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of OA of the knee, based on American College of Rheumatology (ACR) criteria, confirmed by X-ray (K-L Grade II/III within the last year).
- At least moderate or severe pain due to OA in one knee.
- On nonsteroidal anti-inflammatory drug (NSAID) 28 days previous to study start and willing to continue on NSAID throughout study.
- Discontinuation of opioids prior to study start.
- Additional criteria exist.
Who cannot join
- Current or recent infection in the last 7 days; infection requiring hospitalization or parenteral antibiotics within the last 6 months; history of or currently active tuberculosis, hepatitis B or C, or human immunodeficiency virus (HIV).
- Surgery on the index knee within the previous 6 months.
- Trauma or other surgeries within the previous 8 weeks.
- Specific abnormal laboratory values or electrocardiogram abnormalities.
- Gastrointestinal surgery that may interfere with motility or absorption.
- On non-stable dose of bisphosphonates, or any prior denosumab or parathyroid hormone (PTH) therapies.
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- Prior parenteral tumor necrosis factor (TNF) inhibitor or anti-nerve growth factor (NGF) therapies.
- Intramuscular, intravenous or oral corticosteroids within the previous 6 weeks.
- Intra-articular corticosteroids in the index knee within the previous 8 weeks or viscosupplementation in the index knee within the previous 4 months.
- Currently enrolled in or participated in another clinical trial within the previous 3 months.
- Additional criteria exist.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Pfizer Investigational Site
Austin, Texas
Pfizer Investigational Site
Charlotte, North Carolina
Pfizer Investigational Site
Duncansville, Pennsylvania, 16635
Pfizer Investigational Site
Fort Lauderdale, Florida, 33316
Pfizer Investigational Site
Kenosha, Wisconsin
Pfizer Investigational Site
Olive Branch, Mississippi, 38654
Pfizer Investigational Site
Phoenix, Arizona
Pfizer Investigational Site
Pinellas Park, Florida, 33781
Pfizer Investigational Site
Raleigh, North Carolina
Pfizer Investigational Site
Salt Lake City, Utah
Pfizer Investigational Site
Sarasota, Florida, 34232
Pfizer Investigational Site
Watertown, Massachusetts
Pfizer Investigational Site
Winston-Salem, North Carolina
About this study
This is a Phase 2 study, involving a 4-week treatment period, designed to test the ability of investigational study drug ARRY-371797 to reduce pain in patients with moderate to severe pain due to osteoarthritis (OA) of the knee, and to further evaluate the drug's safety. Approximately 150 patients from the US will be enrolled in this study.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- ARRY-371797, p38 inhibitor; oral, Oxycodone hydrochloride (HCl) extended release (ER), opioid agonist; oral, Placebo; oral
- Keywords
- osteoarthritis, knee, pain, NSAID
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARRY-371797, p38 inhibitor; oralDrug
multiple dose, single schedule
Oxycodone hydrochloride (HCl) extended release (ER), opioid agonist; oralDrug
multiple dose, single schedule
Placebo; oralDrug
matching placebo
| Study group | Role | What they receive |
|---|---|---|
| ARRY-371797 | Experimental | Not described Receives: Drug: ARRY-371797, p38 inhibitor; oral |
| Oxycodone HCl ER | Active comparator | Not described Receives: Drug: Oxycodone hydrochloride (HCl) extended release (ER), opioid agonist; oral |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo; oral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the efficacy of the study drug (versus placebo) in terms of change from baseline to week 4 in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score (index knee).
Measured: 4 weeks
Secondary outcomes (3)
Assess the efficacy of the study drug (versus placebo) in terms of change from baseline to week 4 in the WOMAC stiffness and physical function subscale scores (index knee).
Measured: 4 weeks
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, electrocardiograms and vital signs.
Measured: 5 weeks
Characterize the pharmacokinetics of the study drug and metabolite as determined by plasma concentrations.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the KneeStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01366014
- Sponsor's protocol ID
- ARRAY-797-223
- Other IDs
- C4411007
- Status last verified
- Oct 2020
- First submitted
- 2 Jun 2011
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of ARRY-371797 in Patients With Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT01366014
- Acronym / sponsor ID
- ARRAY-797-223
- Conditions
- Osteoarthritis of the Knee
- Keywords
- osteoarthritis, knee, pain, NSAID
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 3 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2 study, involving a 4-week treatment period, designed to test the ability of investigational study drug ARRY-371797 to reduce pain in patients with moderate to severe pain due to osteoarthritis (OA) of the knee, and to further evaluate the drug's safety. Approximately 150 patients from the US will be enrolled in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ARRY-371797 | Experimental | Drug: ARRY-371797, p38 inhibitor; oral |
| Oxycodone HCl ER | Active comparator | Drug: Oxycodone hydrochloride (HCl) extended release (ER), opioid agonist; oral |
| Placebo | Placebo comparator | Drug: Placebo; oral |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of OA of the knee, based on American College of Rheumatology (ACR) criteria, confirmed by X-ray (K-L Grade II/III within the last year).
- At least moderate or severe pain due to OA in one knee.
- On nonsteroidal anti-inflammatory drug (NSAID) 28 days previous to study start and willing to continue on NSAID throughout study.
- Discontinuation of opioids prior to study start.
- Additional criteria exist.
Key exclusion criteria (11 listed)
- Current or recent infection in the last 7 days; infection requiring hospitalization or parenteral antibiotics within the last 6 months; history of or currently active tuberculosis, hepatitis B or C, or human immunodeficiency virus (HIV).
- Surgery on the index knee within the previous 6 months.
- Trauma or other surgeries within the previous 8 weeks.
- Specific abnormal laboratory values or electrocardiogram abnormalities.
- Gastrointestinal surgery that may interfere with motility or absorption.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARRY-371797, p38 inhibitor; oralmultiple dose, single schedule | Drug | ARRY-371797 |
| Oxycodone hydrochloride (HCl) extended release (ER), opioid agonist; oralmultiple dose, single schedule | Drug | Oxycodone HCl ER |
| Placebo; oralmatching placebo | Drug | Placebo |
Primary outcome
Assess the efficacy of the study drug (versus placebo) in terms of change from baseline to week 4 in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score (index knee).
Time frame: 4 weeks
3 secondary outcomes
Assess the efficacy of the study drug (versus placebo) in terms of change from baseline to week 4 in the WOMAC stiffness and physical function subscale scores (index knee).
Time frame: 4 weeks
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, electrocardiograms and vital signs.
Time frame: 5 weeks
Characterize the pharmacokinetics of the study drug and metabolite as determined by plasma concentrations.
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ARRY-371797, p38 inhibitor; oral and Oxycodone hydrochloride (HCl) extended release (ER), opioid agonist; oral in people with Osteoarthritis of the Knee, run by Pfizer at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the efficacy of the study drug (versus placebo) in terms of change from baseline to week 4 in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score (index knee). (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020; AzTrials last refreshed its copy on 7 Nov 2026.